a study of ramucirumab (imc-1121b) with paclitaxel and carboplatin in non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the progression-free survival (pfs) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for stage iiib or iv non-small cell lung cancer

non-small cell lung cancer (nsclc) accounts for 75-80% of all lung cancers. the advanced stages are associated with poor survival rates, a median survival rate of approximately 3.9 months if left untreated. angiogenesis is a process for wound healing and restoring blood flow to tissues after injury. it is the physiological process involving the growth of new blood vessels from pre-existing vessels. angiogenesis may be promoted by growth factors and in diseases such as cancer, where growth factors are over expressed, the body loses the ability to maintain a balanced angiogenesis. this may embellish the existing supplies of blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer growth and survival. ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the growth factor to form new blood vessels, thus reducing the blood supply to the cancer cells.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed nsclc * advanced nsclc * measurable disease (as defined by response evaluation criteria in solid tumors \[recist 1.0\]) * eastern cooperative oncology group (ecog) performance status is ≤ 1 * age ≥ 18 years * adequate hematologic function = an absolute neutrophil count (anc) ≥ 1500/μl, hemoglobin ≥ 9 g/dl, and a platelet count ≥ 100,000/microliter (μl) * adequate hepatic function = a total bilirubin ≤ 1.5 mg/dl transaminases and alkaline phosphatase ≤ 5 x the upper limit of normal (uln) * adequate renal function serum creatinine ≤ 1.5 x uln or calculated creatinine clearance (crcl) \> 60 ml/minute, and urine dipstick for protein \< 1+ (ie, either 0 or trace) * adequate coagulation function, inr ≤ 1.5 and a partial thromboplastin time (ptt) ≤ 5 seconds above uln * adequate contraception * signed informed consent exclusion criteria: * untreated cns metastases * prior bevacizumab therapy * radiologically documented evidence of major blood vessel invasion or encasement by cancer * prior systemic chemotherapy for stage iiib/iv nsclc * prior systemic chemotherapy or radiation therapy for stage i-iiia nsclc \< 1 year prior * any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix * concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy * ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * uncontrolled thrombotic or hemorrhagic disorders * poorly-controlled hypertension * chronic daily treatment with aspirin (\> 325 mg/day) or other known inhibitors of platelet function * history of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon) * serious non-healing wound, ulcer, or bone fracture * undergone major surgery or subcutaneous venous access device placement. post-operative bleeding complications or wound complications from a surgical procedures performed in the last 2 months * elective or a planned major surgery to be performed during the course of the trial * peripheral neuropathy ≥ grade 2 (national cancer institute common toxicity criteria for adverse events, version 3.0 \[nci-ctcae v 3.0\]) * if female, is pregnant or lactating * radiographic evidence of intratumor cavitation * grade 3-4 gastrointestinal bleeding within 3 months prior to study entry

Keywords: non small cell lung cancer lung nsclc